Brief Intervention for Heavy Drinkers

This study has been completed.
Sponsor:
Collaborator:
National Board of Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00728767
First received: August 1, 2008
Last updated: April 13, 2011
Last verified: August 2009
  Purpose

The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.


Condition Intervention Phase
Alcohol Abuse
Other: Brief intervention
Other: Control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 772
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Brief intervention

The intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention.

The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, and a sheet about local alcohol treatment possibilities.

The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.

Employees had been instructed to ask these questions during the intervention: "What are you already doing to restrain your drinking?" And "What can you do more?"

Placebo Comparator: 2 Other: Control group
The intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities.

Detailed Description:

Background and purpose:

The Danish national board of Health has awarded 5.6 million DKR to two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 9 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.

The study will determine whether a brief intervention is effective in lowering self reported alcohol use in heavy drinkers.

Design:

The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:

A) a intervention group receiving a short (about 10 minutes) motivational conversation (build on the principles of motivational interviewing) and two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.

B) a control group receiving two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities.

The study will take place in premises linked to the 'Diet, Smoking, Alcohol and Exercise' nationwide health study.

After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
  • Participants must have responded to an Internet questionnaire.
  • Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).

Exclusion Criteria:

  • Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728767

Locations
Denmark
The municipality of Naestved
Naestved, Næstved, Denmark, 4700
The municipiality of Aeroe
Aeroeskoebing, Denmark, 5970
The municipiality of Albertslund
Albertslund, Denmark, 2620
The municipiality of Broendby
Brøndby, Denmark, 2605
The municipiality of Frederiksberg
Frederiksberg, Denmark, 2000
The municipality of Guldborgsund
Nykøbing F., Denmark, 4800
The municipiality of Faaborg-Midtfyn
Ringe, Denmark, 5750
The municipiality of Silkeborg
Silkeborg, Denmark, 8600
The municipiality of Varde
Varde, Denmark, 6800
Sponsors and Collaborators
University of Southern Denmark
National Board of Health, Denmark
Investigators
Principal Investigator: Anders B. Gottlieb Hansen, cand.techn.soc University of Southern Denmark, National Institute of Public Health
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kit Broholm, National Board of Health Denmark
ClinicalTrials.gov Identifier: NCT00728767     History of Changes
Other Study ID Numbers: NIPH - 1948
Study First Received: August 1, 2008
Last Updated: April 13, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Heavy drinking
Brief intervention
Alcohol prevention
Randomized trial
Motivational interviewing
Intervention Studies
prevention & control

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014